Good day, and thank you for standing by. Welcome to the ERYTECH business update and financial highlights for the second quarter of the year 2021. At this time all participants are in listen-only mode. After the presentation, there will be a answer-and-question session. To ask a question during the session, you need to press star, then one on your telephone keypad, the advised of today's conference may be recorded. If you require operator assistance, please press star, zero. I'd now like to hand the conference over to your speaker today, Gil Beyen, Chief Executive Officer. Please go ahead. Thank you, Liz. Good afternoon, good morning, bonjour à tous. Thank you for joining us for our earnings call to discuss the highlights and financials for the first half of this year. I hope everyone is well and safe today wherever you may be taking today's call. We announced our business and financial update yesterday evening, September 20th. The press release and the first-half earnings presentation can be found in the investor sections of our website. Joining me here today on this call are Dr. Iman El-Hariry, our Chief Medical Officer, together with me here in Boston, and Eric Soyer, our Chief Financial and Chief Operating Officer, dialing in from Lyon. Switching to slide two, before starting, indeed, I would like to draw your attention to the disclaimer to remind you that today's calls include forward-looking statements such as relating to the company's operations, anticipated timelines, and financials. As you know, they all involve risks and uncertainties that could cause actual timings and results to differ materially. Switching to slide three, the agenda for the call. I will, as usual, start with a short introduction and present the key business highlights of the year-to-date, focusing on the more recent ones, the ones that occurred after our last call in May. Iman will then provide an update on the status and the progress of our four clinical programs to date, after which Eric will present the financial results for the first half of the year. He will also summarize the expected milestones for the coming year before we then open up the lines for Q&A, and all three of us will be available to answer your questions afterwards. Moving to slide four, the introduction for anyone new to the company. Here is a brief overview of ERYTECH. ERYTECH, we are the leader in red blood cell-based cancer therapeutics, as you know. Our focus is on targeting cancer cells' altered amino acid metabolism, an increasingly important and exciting area of cancer therapy. We, in this area, have late-stage clinical programs, pancreatic cancer, triple-negative breast cancer, and acute lymphoblastic leukemia. As I noted at our last call, the upcoming quarter, the fourth quarter, is truly a key quarter for ERYTECH with some key inflection points for the company. As you know, we have four clinical programs ongoing, two of them potentially pivotal, potentially supporting an application for regulatory approvals. For both of them, we expect important news this quarter. More on that in a minute. Just to summarize the introduction, we are producing our product in two fully operational facilities, one in Lyon to serve the European market and one in Princeton for the U.S. market. Also in terms of shareholder base, very balanced between Europe and U.S. with a Euronext and a Nasdaq listing with roughly 50/50 shareholder base. The highlights for the year, slide five. Again, we've made critical steps forward since our last call or the first half of the year to bring our lead product, eryaspase, to patients in need, and this both in Europe and the United States. The four highlights I'd like to mention, starting with TRYbeCA-1, of course, our phase III trial in second-line pancreatic cancer. The work towards the final readout continued in full force over the summer and is continuing, and now the eyes are really on the results, which we continue to expect in the fourth quarter of this year. TRYbeCA-1 is, to our knowledge, the largest clinical trial ongoing in second-line metastatic pancreatic cancer and has the potential, if successful, to lead to a treatment paradigm shift against this terrible disease. This study was initiated three years ago, now we are indeed fully. The eyes focused on top-line results not that far away. Iman will tell more about this. Our second highlight is in acute lymphoblastic leukemia, more in the specific in ALL patients who developed hypersensitivities to pegylated asparaginase. Progressing, we had positive data, as you know, presented at ASH. We then had a dialogue ongoing with the FDA, met in a pre-BLA meeting in June, after which in July, we confirmed our intention to submit a BLA by year-end. This obviously subject to successful completion of remaining tasks as discussed during the pre-BLA meeting. Also in June, no, that was in July, we were pleased that we then were granted the Fast Track designation for the treatment of ALL. Now the teams are working indeed to the BLA submission before the end of the year. Third highlight, back to pancreatic cancer, but now first-line, a highlight from our IST trial that is ongoing in Georgetown University. The trial completed its first dose of three patients already before our previous call. In the meantime, the second dose is fully enrolled, and we are eagerly awaiting the final results on safety. If everything continues to go as we have seen so far, we should be able to determine the MTD shortly. Lastly, on this slide, the successful financing, EUR 30 million registered direct offering that was done in May. That prolonged our cash way into the second quarter. Also here I will leave to Eric, who will provide more detail shortly. On the next slide six, you see all of this summarized in an overview. I will not repeat. You see the check marks. There are a lot of achievements over the past months and year. Indeed, a concentration of milestones, two key ones in the fourth quarter, the phase III results and the BLA submission in ALL, but also significant and defining milestones in the coming 12 months or so. I'll stop here, hand over to Iman to provide additional color and detail on our clinical programs and their expected milestone. Iman, the floor is yours. Thank you, Gil. Good morning, United States Good afternoon, Europe. I'll provide a quick update and overview on our three main indications for ARI-0001 as the pancreatic cancer, triple-negative, as well as the ALL indication. Starting at slide number eight. You have seen this slide before. This is our TRYbeCA-1 on a slide. TRYbeCA-1 on a study which is ARI-0001 in combination with chemotherapy in second-line advanced pancreatic cancer. As you know, this study is our phase III pivotal trial, 500 patients, enrolling patients with Stage III and Stage IV disease with good performance status. These patients were randomized to receive chemotherapy with or without ARI-0001. The backbone chemotherapy was a menu of two, either gemcitabine or irinotecan-based chemotherapy. As a pivotal trial, the primary endpoint is overall survival, and we have all expected secondary endpoints, particularly key one is progression-free survival, their investigator's assessment, as well as objective response disease control rate. We'll be looking also at quality of life and safety and biomarkers. The study originally was actually executed in 11 countries in Europe as well as United States. It's almost over almost 100 sites participating in this trial and was co-led by Professor Pascal Hammel and Professor Hidalgo in United States. Just also to remind you of the study plans in terms of the statistical design. The study is set to look at an improvement in overall survival with a hazard ratio of 0.725 in favor of addition of ARI-0001 treatment. This is based on overall median survival in the control arm of six months, and so we're looking at improvement from six to roughly 8.3 months in the active arm. This is a plan for the study. Moving to slide number nine, just to give you also quick highlights what we have done so far. Study completed enrollment end of last year. We ended up with 512 patients in total. We actually were very happy with the study enrollment. This was a major achievement, not only for the company but of course for the patients who participated in the trial despite the pandemic that hit all of us back in early 2020. Which also didn't have a major impact in terms of the enrollment or the quality of the patients participating in this trial. The study had an IDMC on board, and the IDMC met four times during the life of the study so far. The first three meetings were safety reviews. There were no safety issues. Then the last one was conducted last February of this year, and this was our first and only interim analysis for efficacy, but also safety review. Based on their recommendation, the study continued to final analysis. We are expecting the trial results in the first quarter of this year, where I can tell you are all working day and night to make sure that we have the data cleaning and the results planned as guided to the market. I also wanted to make sure that, just to confirm that we continue to be blinded to the study. It's a phase III trial, and we need to integrity of the trial. Moving to slide 10. Switching gears, also in the same indication though, this is our investigator-initiated phase I study in first-line pancreatic cancer, which is by Dr. Noel in Georgetown University. The study is looking to assess the safety and tolerability of ARI-0001 in combination with modified FOLFIRINOX in this setting. FOLFIRINOX is becoming an increasingly popular chemotherapy of choice in that setting, and therefore needs lots of good rationale for us to assess the combinability of our drug with this chemotherapy regimen. As a phase I trial, the primary endpoint is safety and really getting the recommended phase II dose for future study in that setting. Studies started beginning of this year, started with a dose cohort of 75 units. Actually, it is 75 units per kilogram and just there is a typo there. As you know, the dose of ARI-0001, which we are using in our indications, is 100 units per kilogram. We started with slightly lower dose. There was no DLT observed, and therefore, the site, in fact, escalated to the second and final dose cohort, which is 100 units per kilogram. This cohort has already fully enrolled, and we are waiting for the last patient in that cohort to clear for any dose-limiting toxicity. If that is the case, hopefully soon we'll be able to declare our recommended phase II dose, which hopefully will be the 100 units per kilogram. We are expecting these results, again, the confirmation, again, really in the fourth quarter now of this year. That covers pancreatic indications. Also, moving to slide number 11. We also had a webinar at the beginning of this month, where Professor Hidalgo and Dr. Noel, participated in that. It was really a good webinar. Lots of questions were addressed. Basically, the key outcome of this webinar is that, number one, pancreatic cancer continues to be unmet medical need. You know that ONIVYDE so far is the only approved drug in second-line setting, and also, so there is certainly room for new treatments and improving survival in these patients. Moving to slide number 12. Switching gears now to our second indication, which is the triple-negative breast cancer. It's another highly unmet medical need. We are starting with a proof of concept trial, led by Dr. Awada in Jules Bordet in Belgium, in Brussels. This study is a small randomized trial, 65 patients in total in first and second-line settings to assess the clinical activity of ARI-0001 when added to gem/carbo. For this trial is a European only trial, and we have a steering committee that they met, and they actually reviewed the safety profile so far. Again, no issues, given this is again, our first combination, and we did not do a phase I trial. We are expecting our interim data, initial/interim data in the first half of 2022. Moving to slide 13. This will be our next indication, ALL, and this is for us a very exciting opportunity for several reasons. Really, it's addressing, again, another unmet medical need. It's important for the patients who develop hypersensitivity reactions to asparaginase, particularly pegylated asparaginase, which is the standard of care for treating these patients. ALL indication is based on a NOPHO-sponsored study. It was a phase II trial that was presented last year at ASH 2020. In that trial, which enrolled 55 patients in total, patients who have developed hypersensitivity reactions were switched to receive ARI-0001 with the same backbone chemotherapy to be able to complete the intended courses of asparaginase therapy. The trial showed that asparaginase activity was maintained in most, if not all of those patients with a very good safety profile. More importantly, the convenience of treatment since ARI-0001 is a drug that is given once every two weeks, that provides also a better quality of life particularly for the pediatric population. With this, it confirmed our view that we do have an unmet medical need. It's in patients which represent about 15%-20% of this population. While there are two drugs approved, Erwinaze, which has suffered longer-term supply shortage, but newly approved Rylaze by Jazz. There is an important need for a critical need to have an additional option for those patients and the ability, at least, for the convenience of treatment. With ARI-0001, we will end up with two administrations per month as compared to 12- 15 administrations. You can imagine the impact of this number of administration, particularly if you have a kid one year old or two years. It's certainly a factor that needs to be considered. The positive news for us so far that we have met with the FDA last June, three months ago. This is our pre-BLA meeting. Soon after, we have been granted a Fast Track for ALL, which for us is becoming very important as it helps us in our continuous dialogue with the FDA. That's really the whole value of Fast Track designation. We have guided before that we intend to have our submission expected in the fourth quarter. This will be contingent on our successful completion of all the remaining activities. With this, I will stop here and then hand over to Eric Soyer, our Chief Financial and Operating Officer, who will provide us with the financial update and the news flow. Over to you, Eric. Thank you. Thank you very much, Iman. Good morning, everyone. [Foreign language]. We're now moving to slide 15 of that slide deck, reviewing the financial highlights for the first half of this year, and we're starting with P&L information. As you can see, the net loss for the first half of 2021 was EUR 28 million, and that's down EUR 7 million, -20% year-over-year, with a EUR 6.4 million decrease, -18% in operating loss, and a EUR 0.6 million increase in financial income. The EUR 6.4 million decrease in operating loss was attributable to the EUR 5.6 million decrease in preclinical and clinical development expenses, and of course, that's concurrent with the completion of patient enrollment in the company's phase III trial in pancreatic cancer, TRYbeCA-1. Also, a EUR 0.3 million decrease in G&A expenses and a EUR 0.4 million increase in other income, mostly related to R&D tax credits. The EUR 0.6 million increase in financial results was mostly related to foreign currency gains on the U.S. dollar. We are moving to the next slide, 16, for comments on cash. As of June 30, 2021, ERYTECH had cash and cash equivalents totaling EUR 46.3 million, which is approximately $54.9 million. That is compared with EUR 44.4 million, approximately $54.4 million on December 31st last year, and EUR 37.4 million on March 31 this year. That is a EUR 1.4 million increase in cash position during the first half of 2021, and that was the result of a EUR 32.9 million net cash utilization, including EUR 32.6 million in operating activities and EUR 0.3 million in investing activities. Also, a EUR 34.1 million generated in financing activities, and that is including an $8 million placement in the U.S. through the company's at-the-market or ATM equity financing program for net proceeds of EUR 6.4 million. A $30 million reduced direct offering for net proceeds of EUR 22.9 million, and the drawdown of two tranches under the convertible notes, the OCEANE program, the financing agreement that was signed with Alpha Blue Ocean in last year, for net proceeds of EUR 5.7 million. Finally, we have the variation of the U.S. dollar against the euro, and that led to a EUR 0.7 million positive currency exchange impact. Moving to the next slide 17 with a word on our most recent financing initiatives. You remember that on April 29 this year, we announced a registered direct financing with several healthcare-focused, institutional, and accredited investors with a placement of ADSs, American depository shares, at $7.25, that's EUR 6.01 per ADS, and also associated with a 75% warrant coverage with two warrants for an exercise price of EUR 7.50 per share. This registered direct financing associated with the nine OCEANE tranches that was called to date, has extended company's cash horizon to Q2 next year, Q2 2022. This cash horizon could possibly be further extended to Q3 2022 if the company further utilizes the OCEANE agreement, of course, assuming current market price and of course, subject to the regulatory limits of 20% dilution. Finally, moving to the next slide, 18, I want to quickly summarize the upcoming key milestones before we'll start the Q&A session. That's, of course, the top-line results for TRYbeCA-1, the phase III trial of eryaspase in pancreatic cancer. As explained by Gil and Iman, we expect those top-line results quite soon in Q4 2021. We also, before the end of the year, have the potential BLA filing of eryaspase. That's for hypersensitive patients, of ALL patients. Looking forward to potentially filing a BLA dossier before the end of the year. We'll have the determination of the MTD, the maximum tolerated dose in rESPECT, the phase I trial in first-line pancreatic cancer, also before the end of the year. Towards the first half of next year, we look for the potential BLA filing for eryaspase in second-line pancreatic cancer following the top-line results of TRYbeCA-1, and also the initial data from the phase II trial in breast cancer, the current ongoing TRYbeCA-2 trial. That's also expected in the first half of 2022. With that, I would like to thank you already for your attention, and I will now open the call for any questions you may have. Again, I will be repeating myself and reminding any of you who would like to ask questions in French that you are, of course, very welcome to do so.[Foreign language] Operator, please. Back now over to you. If you like to ask question at this time, please press the star and the number one key on your touch-tone telephone. That is star then one if you like to ask a question. Again that is star then one if you like to ask a question. We have a question from Boris Peaker with Cowen. Good morning. Can you hear me? Yes, Boris. Good morning. How are you? Just good. How are you? A question that comes up frequently is how does the patient enrollment in your pivotal pancreatic cancer compare to the phase II study in terms of geography, age, or any other characteristics, as well as any kind of follow-up care differences? I'll leave this to Iman to answer. Hi. Good morning, Boris. Compared to the phase II trial, the overall patient characteristics are highly similar to what we have in terms of the inclusion/exclusion criteria. The real difference here is, which we don't believe is going to have any impact, is that phase II trial was a French-only study, whereas the TRYbeCA-1 trial naturally was a global trial in Europe and U.S. That is just a geographical difference. France remains still our highest enrolling country in the phase III trial, followed by Spain. With that in mind, we actually compared to the phase II trial. If you remember, most patients received FOLFIRINOX or FOLFIRI or FOLFOX in the first line. Almost 90% of our patients in the second-line were gemcitabine-based therapy in the phase III trial. Thus we expecting also to have more patients receiving gem/Abraxane in the second line. It's not going to be 90%. I think probably will be 2/3- 1/3. That's what will be the difference. We have two webinars, and it's actually the same view from Professor Hidalgo, which confirms also our view, which is we don't believe that the viable chemotherapy will make really much of a difference in terms of the activity of eryaspase in combination with either choices. Otherwise, for some, performance status is the same. Of course progression after first-line therapy and many other inclusion/exclusion criteria, they're actually the same. Great. Well, thank you very much. We all look forward to the big data reveal. Thanks for taking my question. Thank you, Boris. I'm not showing any further questions at this time. I think if no further question, we must have been very clear. I want to thank you all for your attention, for your continued support. As Boris Peaker said it's now indeed looking forward to the data in the next quarter to come. We'll obviously keep you posted as always. In the meantime, wish you a great day and great afternoon in Europe. Thank you all. Take care. Bye-bye. This concludes today's conference call. Thank you for participating. You may now disconnect.
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